- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04753190
Light Timing Study (ALT)
Adolescent Circadian Phase Shifts: Novel Time-of-day Targets for Bright Light
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will complete a 14-day protocol. On days 1-7, participants will sleep at home on a stable sleep schedule that requires 9 h of time in bed in the dark. This will ensure that participants are not sleep deprived before beginning the lab sessions. Wake time will be the average of the self-reported wake-up time (± 15 mins) before the study begins measured from pre-study sleep logs collected for a week or more. Bedtime will be 9 h before wake-up time. A device worn on the wrist that measures activity (actigraph), sleep diaries, and daily telephone messages will monitor compliance to the sleep schedule. Participants will visit the lab at least once during this week to download and review their data. If participants are not compliant to the sleep schedule, they will be dropped from the study.
On days 8-13, participants will live in the laboratory for seven days. On day 8, participants will arrive at the laboratory in the afternoon, and shortly after, will begin a baseline circadian phase assessment to determine baseline dim light melatonin onset (DLMO), a reliable marker of the circadian timing system. On day 9, participants will sleep on their stable 9-h sleep schedule in the laboratory. Their 9-h fixed sleep schedule will be shifted by 1 h per day over 3 days. Participants will sleep in dark bedrooms in the lab. During scheduled wake, participants will remain awake in normal dim room light except during bright light sessions, when light will range from 5000 to 7000 lux. Study groups will differ by the light exposure they receive during the lab sessions. In the afternoon bright light (ABL) group, participants will be exposed to 3 h of bright light on 3 consecutive afternoons. On the first day (day 10), light boxes will be turned on 5 h after fixed wake-up time. Then, the start of the light exposure will move 1 h earlier each day. In the morning bright light (MBL) group, participants will be exposed to 3 consecutive mornings of 3 h of bright light. On the morning of day 11, the 3-h bright light exposure will begin 1 h before their stable wake-up time. In the morning + afternoon bright light (MBL + ABL) group, bright light will begin at the same times as the ABL and MBL groups and participants will received the same duration of bright light per day (3 h) as the ABL and MBL groups because the duration of each exposure will be 1.5 h instead of 3 h. Both bright light exposures will move 1 h earlier on subsequent days. In the room light control group, participants will complete the same 7-day lab session, except remain in dim room lighting. All participants will complete a final circadian phase assessment at the end of the 7-day lab session (day 13).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stephanie J Crowley, PhD
- Phone Number: 3-4783 (312) 563-4783
- Email: Stephanie_J_Crowley@Rush.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Recruiting
- Rush University Medical Center
-
Principal Investigator:
- Stephanie Crowley, PhD
-
Contact:
- Allison Monterastelli
- Phone Number: 312-942-9260
- Email: sleep_study_2@rush.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- between 18-20 years old
- lives in or near Chicago, IL
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Dim Room Light Control
Participants in the dim room light control group will not receive any bright light exposure.
|
All participants will be assigned a 9-h sleep opportunity for the first week of the 2-week study.
This will ensure that adolescents are not sleep restricted before living in the laboratory during the second week of the study.
The 9-h sleep schedule will be individually timed from his/her averaged wake time (± 15 mins) before the study begins.
Assigned bedtime will be 9 h before wake.
For all participants, their assigned baseline sleep/wake schedule will gradually shift earlier over 3 days in the laboratory to facilitate the phase advance shift of the circadian system.
|
|
Experimental: Morning Bright Light Only (MBL)
Participants in the morning bright light (MBL) group will receive a 3-h bright light exposure from 2 light boxes on 3 consecutive mornings in the laboratory.
Bright light will be timed for each individual based on their baseline sleep schedule to shift the circadian timing system earlier ("phase advance").
|
All participants will be assigned a 9-h sleep opportunity for the first week of the 2-week study.
This will ensure that adolescents are not sleep restricted before living in the laboratory during the second week of the study.
The 9-h sleep schedule will be individually timed from his/her averaged wake time (± 15 mins) before the study begins.
Assigned bedtime will be 9 h before wake.
For all participants, their assigned baseline sleep/wake schedule will gradually shift earlier over 3 days in the laboratory to facilitate the phase advance shift of the circadian system.
|
|
Experimental: Afternoon Light Only (ABL)
Participants in the afternoon bright light (ABL) group will receive a 3-h bright light exposure from 2 light boxes on 3 consecutive afternoons in the laboratory.
Bright light will be timed for each individual based on their baseline sleep schedule to shift the circadian timing system earlier ("phase advance").
|
All participants will be assigned a 9-h sleep opportunity for the first week of the 2-week study.
This will ensure that adolescents are not sleep restricted before living in the laboratory during the second week of the study.
The 9-h sleep schedule will be individually timed from his/her averaged wake time (± 15 mins) before the study begins.
Assigned bedtime will be 9 h before wake.
For all participants, their assigned baseline sleep/wake schedule will gradually shift earlier over 3 days in the laboratory to facilitate the phase advance shift of the circadian system.
|
|
Experimental: Morning + Afternoon Light (MBL+ ABL)
Participants in the morning bright light + afternoon bright light (MBL+ ABL) group will receive bright light from 2 light boxes on 3 consecutive days in the laboratory.
The morning exposure will be 1.5 h and the afternoon exposure will be 1.5 h.
Bright light exposures will be timed for each individual based on their baseline sleep schedule to shift the circadian timing system earlier ("phase advance").
|
All participants will be assigned a 9-h sleep opportunity for the first week of the 2-week study.
This will ensure that adolescents are not sleep restricted before living in the laboratory during the second week of the study.
The 9-h sleep schedule will be individually timed from his/her averaged wake time (± 15 mins) before the study begins.
Assigned bedtime will be 9 h before wake.
For all participants, their assigned baseline sleep/wake schedule will gradually shift earlier over 3 days in the laboratory to facilitate the phase advance shift of the circadian system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dim Light Melatonin Onset (DLMO) Phase Shift Change
Time Frame: Change in DLMO phase from baseline (day 8) to final phase assessment (day 13)
|
Saliva sampling for the baseline DLMO will begin 6 hours before baseline bedtime and end 2 hours after baseline bedtime to capture the rise of endogenous melatonin.
Sampling for the final DLMO will begin 7 hours before baseline bedtime and end 2 hours after baseline bedtime.
Participants remain awake and seated in comfortable recliners in dim light (< 5 lux), except when they need to use the adjoining restroom (also < 5 lux).
Saliva samples are collected every 30 minutes using Salivettes, The samples are immediately centrifuged and frozen, and later shipped on dry ice to SolidPhase, Inc. (Portland, ME), where they are analyzed for melatonin using direct radioimmunoassay (RIA).
We compute the DLMO using a 4 pg/mL threshold; the time at which melatonin values surpass this threshold is the DLMO.
Baseline - Final DLMO will define the phase shift change of the central circadian clock.
|
Change in DLMO phase from baseline (day 8) to final phase assessment (day 13)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01HL151512 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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